WO2002060337A2 - Polymere resorbable enrobe et procede de fabrication associe - Google Patents
Polymere resorbable enrobe et procede de fabrication associe Download PDFInfo
- Publication number
- WO2002060337A2 WO2002060337A2 PCT/US2001/048428 US0148428W WO02060337A2 WO 2002060337 A2 WO2002060337 A2 WO 2002060337A2 US 0148428 W US0148428 W US 0148428W WO 02060337 A2 WO02060337 A2 WO 02060337A2
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- ceramic
- substrate
- coating
- resorbable
- providing
- Prior art date
Links
- 229920000642 polymer Polymers 0.000 title claims abstract description 42
- 238000004519 manufacturing process Methods 0.000 title description 2
- 239000000919 ceramic Substances 0.000 claims abstract description 70
- 239000000463 material Substances 0.000 claims abstract description 63
- 238000000576 coating method Methods 0.000 claims abstract description 40
- 239000011248 coating agent Substances 0.000 claims abstract description 39
- 239000000758 substrate Substances 0.000 claims description 49
- 239000002904 solvent Substances 0.000 claims description 30
- 239000000843 powder Substances 0.000 claims description 28
- 239000000203 mixture Substances 0.000 claims description 25
- 239000002245 particle Substances 0.000 claims description 23
- 238000000034 method Methods 0.000 claims description 21
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 claims description 14
- 229920005596 polymer binder Polymers 0.000 claims description 11
- 239000002491 polymer binding agent Substances 0.000 claims description 11
- 238000009826 distribution Methods 0.000 claims description 9
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 claims description 8
- AEMRFAOFKBGASW-UHFFFAOYSA-N Glycolic acid Chemical compound OCC(O)=O AEMRFAOFKBGASW-UHFFFAOYSA-N 0.000 claims description 8
- OSGAYBCDTDRGGQ-UHFFFAOYSA-L calcium sulfate Chemical compound [Ca+2].[O-]S([O-])(=O)=O OSGAYBCDTDRGGQ-UHFFFAOYSA-L 0.000 claims description 8
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 claims description 8
- 229910019142 PO4 Inorganic materials 0.000 claims description 7
- 230000003647 oxidation Effects 0.000 claims description 7
- 238000007254 oxidation reaction Methods 0.000 claims description 7
- 235000021317 phosphate Nutrition 0.000 claims description 7
- XEKOWRVHYACXOJ-UHFFFAOYSA-N Ethyl acetate Chemical compound CCOC(C)=O XEKOWRVHYACXOJ-UHFFFAOYSA-N 0.000 claims description 6
- 150000001450 anions Chemical class 0.000 claims description 6
- QXJJQWWVWRCVQT-UHFFFAOYSA-K calcium;sodium;phosphate Chemical compound [Na+].[Ca+2].[O-]P([O-])([O-])=O QXJJQWWVWRCVQT-UHFFFAOYSA-K 0.000 claims description 6
- 150000001768 cations Chemical class 0.000 claims description 6
- 239000003795 chemical substances by application Substances 0.000 claims description 6
- 150000003013 phosphoric acid derivatives Chemical class 0.000 claims description 6
- 229910001467 sodium calcium phosphate Inorganic materials 0.000 claims description 6
- BVKZGUZCCUSVTD-UHFFFAOYSA-M Bicarbonate Chemical compound OC([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-M 0.000 claims description 5
- 239000011159 matrix material Substances 0.000 claims description 5
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 claims description 4
- BVKZGUZCCUSVTD-UHFFFAOYSA-L Carbonate Chemical compound [O-]C([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-L 0.000 claims description 4
- SECXISVLQFMRJM-UHFFFAOYSA-N N-Methylpyrrolidone Chemical compound CN1CCCC1=O SECXISVLQFMRJM-UHFFFAOYSA-N 0.000 claims description 4
- 150000001408 amides Chemical class 0.000 claims description 4
- 150000008064 anhydrides Chemical class 0.000 claims description 4
- 239000011575 calcium Substances 0.000 claims description 4
- 229910052791 calcium Inorganic materials 0.000 claims description 4
- 229910000019 calcium carbonate Inorganic materials 0.000 claims description 4
- 239000001506 calcium phosphate Substances 0.000 claims description 4
- LZCLXQDLBQLTDK-UHFFFAOYSA-N ethyl 2-hydroxypropanoate Chemical compound CCOC(=O)C(C)O LZCLXQDLBQLTDK-UHFFFAOYSA-N 0.000 claims description 4
- 229910052588 hydroxylapatite Inorganic materials 0.000 claims description 4
- 239000004310 lactic acid Substances 0.000 claims description 4
- 235000014655 lactic acid Nutrition 0.000 claims description 4
- 229910000392 octacalcium phosphate Inorganic materials 0.000 claims description 4
- XYJRXVWERLGGKC-UHFFFAOYSA-D pentacalcium;hydroxide;triphosphate Chemical compound [OH-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O XYJRXVWERLGGKC-UHFFFAOYSA-D 0.000 claims description 4
- 239000011148 porous material Substances 0.000 claims description 4
- YIGWVOWKHUSYER-UHFFFAOYSA-F tetracalcium;hydrogen phosphate;diphosphate Chemical compound [Ca+2].[Ca+2].[Ca+2].[Ca+2].OP([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O YIGWVOWKHUSYER-UHFFFAOYSA-F 0.000 claims description 4
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 claims description 4
- 229910000391 tricalcium phosphate Inorganic materials 0.000 claims description 4
- 229940078499 tricalcium phosphate Drugs 0.000 claims description 4
- 235000019731 tricalcium phosphate Nutrition 0.000 claims description 4
- QAOWNCQODCNURD-UHFFFAOYSA-L Sulfate Chemical compound [O-]S([O-])(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-L 0.000 claims description 3
- BITYAPCSNKJESK-UHFFFAOYSA-N potassiosodium Chemical compound [Na].[K] BITYAPCSNKJESK-UHFFFAOYSA-N 0.000 claims description 3
- 229940116333 ethyl lactate Drugs 0.000 claims description 2
- 239000000560 biocompatible material Substances 0.000 claims 1
- 150000004040 pyrrolidinones Chemical class 0.000 claims 1
- 238000013461 design Methods 0.000 abstract description 2
- 210000000988 bone and bone Anatomy 0.000 description 31
- 239000011230 binding agent Substances 0.000 description 28
- 206010017076 Fracture Diseases 0.000 description 10
- 239000002002 slurry Substances 0.000 description 10
- 208000010392 Bone Fractures Diseases 0.000 description 8
- 239000007943 implant Substances 0.000 description 8
- 238000001356 surgical procedure Methods 0.000 description 6
- 239000012634 fragment Substances 0.000 description 5
- 230000008901 benefit Effects 0.000 description 4
- 229910001092 metal group alloy Inorganic materials 0.000 description 4
- 229920001432 poly(L-lactide) Polymers 0.000 description 4
- 239000000243 solution Substances 0.000 description 4
- 239000000725 suspension Substances 0.000 description 4
- 230000015572 biosynthetic process Effects 0.000 description 3
- 238000005524 ceramic coating Methods 0.000 description 3
- 239000002131 composite material Substances 0.000 description 3
- 239000010410 layer Substances 0.000 description 3
- 230000008439 repair process Effects 0.000 description 3
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- 229910010293 ceramic material Inorganic materials 0.000 description 2
- 229920001577 copolymer Polymers 0.000 description 2
- 239000002537 cosmetic Substances 0.000 description 2
- 238000001704 evaporation Methods 0.000 description 2
- 230000008020 evaporation Effects 0.000 description 2
- 238000011068 loading method Methods 0.000 description 2
- 239000002184 metal Substances 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 238000005245 sintering Methods 0.000 description 2
- 239000002344 surface layer Substances 0.000 description 2
- 210000001519 tissue Anatomy 0.000 description 2
- 238000012546 transfer Methods 0.000 description 2
- 229910000684 Cobalt-chrome Inorganic materials 0.000 description 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 1
- ZOKXTWBITQBERF-UHFFFAOYSA-N Molybdenum Chemical compound [Mo] ZOKXTWBITQBERF-UHFFFAOYSA-N 0.000 description 1
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 description 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 description 1
- 229930006000 Sucrose Natural products 0.000 description 1
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 description 1
- 239000013543 active substance Substances 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 1
- 230000002902 bimodal effect Effects 0.000 description 1
- 230000037176 bone building Effects 0.000 description 1
- 230000008468 bone growth Effects 0.000 description 1
- 150000004649 carbonic acid derivatives Chemical class 0.000 description 1
- 238000004814 ceramic processing Methods 0.000 description 1
- 239000011247 coating layer Substances 0.000 description 1
- 239000010952 cobalt-chrome Substances 0.000 description 1
- 239000000470 constituent Substances 0.000 description 1
- 239000008121 dextrose Substances 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 239000002657 fibrous material Substances 0.000 description 1
- 238000010304 firing Methods 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 125000005456 glyceride group Chemical group 0.000 description 1
- 230000012010 growth Effects 0.000 description 1
- 230000035876 healing Effects 0.000 description 1
- 238000002513 implantation Methods 0.000 description 1
- 230000028709 inflammatory response Effects 0.000 description 1
- 230000010354 integration Effects 0.000 description 1
- 230000003993 interaction Effects 0.000 description 1
- 230000007794 irritation Effects 0.000 description 1
- 238000005304 joining Methods 0.000 description 1
- JJTUDXZGHPGLLC-UHFFFAOYSA-N lactide Chemical compound CC1OC(=O)C(C)OC1=O JJTUDXZGHPGLLC-UHFFFAOYSA-N 0.000 description 1
- 230000000873 masking effect Effects 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
- 150000002739 metals Chemical class 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 229910052750 molybdenum Inorganic materials 0.000 description 1
- 239000011733 molybdenum Substances 0.000 description 1
- 230000000399 orthopedic effect Effects 0.000 description 1
- 239000010452 phosphate Substances 0.000 description 1
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 1
- 229920002959 polymer blend Polymers 0.000 description 1
- 239000002861 polymer material Substances 0.000 description 1
- 229910052700 potassium Inorganic materials 0.000 description 1
- 239000011591 potassium Substances 0.000 description 1
- 230000001737 promoting effect Effects 0.000 description 1
- HNJBEVLQSNELDL-UHFFFAOYSA-N pyrrolidin-2-one Chemical compound O=C1CCCN1 HNJBEVLQSNELDL-UHFFFAOYSA-N 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 239000012047 saturated solution Substances 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- CDBYLPFSWZWCQE-UHFFFAOYSA-L sodium carbonate Substances [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 description 1
- 229910000029 sodium carbonate Inorganic materials 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 210000004872 soft tissue Anatomy 0.000 description 1
- 239000011877 solvent mixture Substances 0.000 description 1
- 238000009987 spinning Methods 0.000 description 1
- 230000007480 spreading Effects 0.000 description 1
- 238000003892 spreading Methods 0.000 description 1
- 239000010935 stainless steel Substances 0.000 description 1
- 229910001220 stainless steel Inorganic materials 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 239000005720 sucrose Substances 0.000 description 1
- 150000003467 sulfuric acid derivatives Chemical class 0.000 description 1
- 238000000194 supercritical-fluid extraction Methods 0.000 description 1
- 239000010936 titanium Substances 0.000 description 1
- 229910052719 titanium Inorganic materials 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- 238000001291 vacuum drying Methods 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/58—Materials at least partially resorbable by the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/28—Materials for coating prostheses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/08—Materials for coatings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/148—Materials at least partially resorbable by the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2420/00—Materials or methods for coatings medical devices
- A61L2420/04—Coatings containing a composite material such as inorganic/organic, i.e. material comprising different phases
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/25—Web or sheet containing structurally defined element or component and including a second component containing structurally defined particles
- Y10T428/252—Glass or ceramic [i.e., fired or glazed clay, cement, etc.] [porcelain, quartz, etc.]
Definitions
- This invention generally relates to coated polymer materials and, more particularly, to a resorptive polymer coat having a ceramic polymer blend which, when used individually or in combination, provides a highly tunable resorption time and a means of supplying bone forming elements.
- the repair of separated or dislocated bone fragments or segments following bone surgeries requires realignment of the separated or dislocated fragments or segments and subsequent secure fixation for promoting proper natural rejoinder of these bone fragments or segments.
- the presence of relative motion of the bone fragments or segments at a fracture or osteotomy location may result in irritation of the surrounding tissues, nonunion between the bone fragments, and an extension of the time of fracture healing. It is therefore desirable to accomplish as completely as possible an immobilization of the fracture or osteotomy site. This involves the relative fixation of affected bone segments relative to each other and in relation to the surrounding bone structure.
- Known methods for providing fixation between adjacent bone portions have included the use of metallic plates of varying configurations, which are secured across osteotomies or fracture sites by metallic bone screws.
- osteosynthesis plates had to be made relatively thick so as to provide the requisite strength and resorption time, which tended to make the osteosynthesis plates have an unwanted cosmetic appearance when implanted.
- a bioresorbable material having a ceramic and polymer coating.
- the ceramic and polymer coating increases the tailorability and tuneability of resorption rates and properties and allows for increases in implant design flexibility by virtue of its simplicity. Also as the coating comprises of a resorbable ceramic, it helps in bone integration and formation.
- a resorptive material includes a polymer and ceramic coating to control the osseoconductive properties of the coating.
- a resorbable ceramic powder is deposited onto a substrate by use of a resorbable polymer binder. It is possible to use a combination of differing ceramic compositions as well as ceramic powder particle sizes to adjust resorption properties. Similarly, it is possible to use a combination of resorbable polymeric binders in different amounts to adjust resorption time.
- a material having a biocompatible resorbable ceramic with biologically acceptable cations such as calcium, sodium, potassium and anions of phosphates in various oxidation states, carbonates, bicarbonates and sulfates including but not limited to calcium sodium phosphate, calcium sulfate, hydroxyapatite, calcium carbonate, tricalcium phosphate and octacalcium phosphate or a mixture of resorbable ceramics.
- a method of forming a resorbable coating material onto a substrate includes the steps of forming a mixture of the polymer binder, a resorbable ceramic powder and a solvent. The mixture is disposed onto the substrate at a fixed thickness. The solvent is either extracted or evaporated off, leaving a coating of ceramic powder coupled to the substrate by a polymer binder.
- Use of the present invention provides a substrate material coated with a resorbable layer that affects resorption rate.
- the coating material is formed of a resorbable polymer binder and resorbable ceramic materials.
- the resorption rate of the coating can be significantly slowed down.
- the aforementioned disadvantages associated with the currently available resorbable materials have been substantially reduced or eliminated.
- FIG. 1 is a cross-section of a coated substrate conforming to the teachings of the current invention
- FIG. 2 is a cross-section of a multi-layer coating conforming to the teachings of the current invention
- FIG. 3 is a flow chart describing the method of producing the coating of the invention.
- FIG. 4 is a bone plate formed of the coated material of the invention.
- FIG. 1 discloses a coating 20 of the current invention disposed on a substrate 21.
- the primary constituent of the coating 20 is ceramic powder 22.
- the ceramic powder 22 is a bio-compatible resorbable ceramic with cations of calcium, sodium potassium and anions of phosphates in various oxidation states.
- the ceramic 22 is a phosphate, carbonate, bicarbonate or sulfate including but not limited to calcium sodium phosphate, calcium sulfate, hydroxyapatite, calcium carbonate, tricalcium phosphate and octacalcium phosphate or mixtures of these resorbable ceramics.
- the particle sizes of the embedded ceramic 22 being used for the coatings 20 are generally below 200 microns. It is preferable that the particles have a mean size of 50 microns with a distribution of about 25 microns. It is possible to use tailored size distribution such as a bimodal particle size distribution to modify the overall performance of the device.
- the coating 20 disclosed does not require the use of a ceramic powder binder 23 in the usual sense.
- binders usually some kind of polymer
- the subsequent sintering processes ensure structural integrity of powder formed ceramics by joining the individual powder particles together.
- the binders 23 used in the present invention, and for that matter substrate polymers are biocompatible and resorbable polymers, copolymers or blends such as those composed of lactic acid, glycolic acid, amides, anhydrides, orthroesters, dioxanones and many others.
- the weight percentage and molecular weight of the binder 23 is chosen to affect the resorption rate of the final structure.
- the binders 23 are not removed from the resulting structure by means of heat and oxidation.
- the binder materials 23 remain within the structure until resorbed after implantation.
- the binder material 23 is combined with the ceramic powder 22 by the use of a solvent 24.
- the binder polymer 23 is dissolved within the solvent 24 and the ceramic powder 22 is added to form a slurry.
- the composition of the slurry preferably holds the ceramic powder 22 in suspension in the dissolved polymer/solvent mixture. There may be no chemical interaction between the ceramic powder 22 and this solution.
- this slurry can also have pore forming agents such as sugar (sucrose or dextrose), salt (sodium chloride or carbonate and bicarbonate) and biologically active agents.
- the slurry may also have bio-compatible deflocculating agents (usually less than a 1% if any) to assist in keeping the ceramic particles held in suspension in the solvent 24.
- solvents 24 are but not limited to acetone, pyrrolidone such as N-methyl-2-pyrrolidone, ethyl acetate and ethyl lactate. It is possible to use a mixture of solvents to adjust the density and viscosity of the solution as well as the amount of polymer binder to be dissolved. As with all biomedical applications, the solvents used should be benign and least toxic. As such, the solvent must be removed by well known processes such as vacuum drying or super critical extraction.
- the binder polymer 23 in the slurry is the same as the substrate polymer 21 which is to be coated. It is also envisioned that the binder polymer 23 can be different than the substrate polymer 21. Medical application demands that the binder 23 and substrate polymer 21 be biocompatible and resorbable. In the event that the binder and substrate polymers are different, the solvent (or mixture of solvents) to be used must be able to dissolve or at least make both the substrate polymer 21 and the binder material 23 sticky.
- a composite structure would form of resorbable ceramic powder 22 in a resorbable binder polymer matrix 23.
- This ceramic powder 22 is bound in the polymer matrix 23 of the precipitated resorbable polymer, leaving a resorbable composite which can be used as an implant.
- the solvents in the slurry When the slurry is poured onto the substrate polymer 21 and is allowed to evaporate on the substrate polymer 21 , the solvents in the slurry also partially dissolves the substrate polymer 21. Eventually, the solvent will evaporate leaving the ceramic powder 22 bound by the binder 23 and partially dissolved substrate polymer 21.
- the ratio of the binder polymer 23 to the solvent 24 can have a wide range, from very dilute to saturation. If LACTOSORB, offered by Biomet, Inc. of Warsaw, Indiana, is used as binder polymer 23, the ratio of the binder polymer 23 to solvent 24 is between 9 to 12g to 100 ml acetone. For saturation, the ratio is 15g/100ml acetone. In this range of solution composition, the other variable is the ceramic powder 22 volume fraction. By varying the weight percentage of ceramic powder 22 to binder polymer 23, the percentage of polymer matrix 23 in the resulting product can be adjusted. So, the slurry could have a composition of dilute to saturated solution with particle volume fraction ranging from sparse to heavy.
- the preferred composition of the slurry will depend on the application or the characteristics of the coating. Intuitively, if a longer resorption time were required, the binder polymer 23 would be close to saturation (almost 15g of LACTOSORB per 100 ml acetone. For devices showing faster resorption, a lower concentration solution would be used. The other variable i.e., ceramic powder 22 volume fraction should not affect resorption rate, but the ceramic composition will affect resorption characteristics.
- coating layers can be applied to the substrate. These layers can be in any order and can have varying ceramic volume fractions ranging from none to heavy loading as well as varying powder size. By varying the ceramic material, and the binder, resorption rates can be varied.
- the biocompatible resorbable ceramic coating 20 is formed as follows.
- a binder polymer 23 is dissolved within a solvent 24.
- the ceramic powder 22 is mixed into the solvent 24 material so as to hold the ceramic powder 22 in suspension. Deflocculating additives may be used to hold the ceramic powders 22 in suspension within the mixture.
- the mixture is then deposited onto a substrate material 21. Should the substrate material 21 be of a polymer which is dissolvable by the particular solvent used, the surface layer of the substrate material begins to dissolve.
- the solvent is removed by evaporation. The ceramic particles 22 are then imbedded within the dissolved surface layer of the substrate as well as in the binder material.
- the slurry may be cast on a glass or other substrate with or without the benefit of spreading assisted by spinning.
- laminated structures of resorbable ceramic-polymer composites are fabricated.
- the individual laminates can have varying particle size distribution, loading and composition.
- Pore forming agents can be added to the solvent. These agents function to create pores within the binder material and allow for a variation of the resorption time.
- a resorbable substrate material 21 having a resorbable polymer ceramic coating 20 is formed.
- the coating allows a user to adjust the resorption rate of the material.
- a standard bone plate 34 is shown using the aforementioned material.
- the resorption rate of a bone plate used in orthopedic procedures of the current invention can have tailorable resorption properties.
- the variable resorption rates lead to a significant benefit not seen in prior bone plate structures.
- the resorption of the bone plate can be significantly slower than those bone plates formed by the substrate material alone. In particular, this can be useful in patients where bone regrowth would be expected to be much slower and, therefore, the support caused by the bone plate would need to be utilized by the patient for a much longer period of time.
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Medicinal Chemistry (AREA)
- Dermatology (AREA)
- Chemical & Material Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Surgery (AREA)
- Vascular Medicine (AREA)
- Materials For Medical Uses (AREA)
Abstract
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP01998045A EP1341473A4 (fr) | 2000-12-15 | 2001-12-14 | Polymere resorbable enrobe et procede de fabrication associe |
AU2002249805A AU2002249805A1 (en) | 2000-12-15 | 2001-12-14 | Coated resorbable polymer and method of making the same |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/738,615 US6518328B2 (en) | 2000-12-15 | 2000-12-15 | Coated resorbable polymer and method of making the same |
US09/738,615 | 2000-12-15 |
Publications (2)
Publication Number | Publication Date |
---|---|
WO2002060337A2 true WO2002060337A2 (fr) | 2002-08-08 |
WO2002060337A3 WO2002060337A3 (fr) | 2003-02-27 |
Family
ID=24968746
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2001/048428 WO2002060337A2 (fr) | 2000-12-15 | 2001-12-14 | Polymere resorbable enrobe et procede de fabrication associe |
Country Status (4)
Country | Link |
---|---|
US (1) | US6518328B2 (fr) |
EP (1) | EP1341473A4 (fr) |
AU (1) | AU2002249805A1 (fr) |
WO (1) | WO2002060337A2 (fr) |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2007127868A3 (fr) * | 2006-04-27 | 2008-01-10 | Phillips Plastics Corp | Stent composé |
US9101505B2 (en) | 2006-04-27 | 2015-08-11 | Brs Holdings, Llc | Composite stent |
Families Citing this family (21)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CA2433550A1 (fr) * | 2001-01-02 | 2002-07-11 | Advanced Ceramics Research, Inc. | Compositions et procedes destines a des applications biomedicales |
US20020120340A1 (en) * | 2001-02-23 | 2002-08-29 | Metzger Robert G. | Knee joint prosthesis |
US7497874B1 (en) | 2001-02-23 | 2009-03-03 | Biomet Manufacturing Corp. | Knee joint prosthesis |
ATE359836T1 (de) * | 2001-09-24 | 2007-05-15 | Millenium Biologix Inc | Poröse keramische komposit-knochenimplantate |
US7067169B2 (en) * | 2003-06-04 | 2006-06-27 | Chemat Technology Inc. | Coated implants and methods of coating |
DE102004063794A1 (de) * | 2004-12-30 | 2006-07-13 | Universität Duisburg-Essen | Implantat |
US7740794B1 (en) * | 2005-04-18 | 2010-06-22 | Biomet Sports Medicine, Llc | Methods of making a polymer and ceramic composite |
EP3517137A1 (fr) | 2005-11-14 | 2019-07-31 | Biomet 3I, LLC | Dépôt de nanoparticules discrètes sur une surface d'implant |
US7790080B2 (en) * | 2005-11-22 | 2010-09-07 | National Taiwan University | Method for forming a bioartificial guidance conduit |
CN100428964C (zh) * | 2006-06-29 | 2008-10-29 | 武汉理工大学 | RGD多肽接枝聚(羟基乙酸-L-赖氨酸-L-乳酸)/β-磷酸三钙复合材料及其制备方法 |
EP2079401B1 (fr) * | 2006-10-24 | 2019-05-22 | Biomet 3i, LLC | Déposition de nanoparticules discrètes sur la surface nanostructurée d'un implant |
US8163028B2 (en) | 2007-01-10 | 2012-04-24 | Biomet Manufacturing Corp. | Knee joint prosthesis system and method for implantation |
JP5448842B2 (ja) | 2007-01-10 | 2014-03-19 | バイオメト マニファクチャリング コーポレイション | 膝関節プロテーゼシステムおよび埋込み方法 |
US8562616B2 (en) | 2007-10-10 | 2013-10-22 | Biomet Manufacturing, Llc | Knee joint prosthesis system and method for implantation |
US8328873B2 (en) | 2007-01-10 | 2012-12-11 | Biomet Manufacturing Corp. | Knee joint prosthesis system and method for implantation |
US8187280B2 (en) | 2007-10-10 | 2012-05-29 | Biomet Manufacturing Corp. | Knee joint prosthesis system and method for implantation |
US9302030B2 (en) * | 2007-08-07 | 2016-04-05 | Abbott Cardiovascular Systems Inc. | Prohealing piezoelectric coatings |
WO2009097218A1 (fr) | 2008-01-28 | 2009-08-06 | Biomet 3I, Llc | Surface d'implant présentant un caractère hydrophile augmenté |
US8444699B2 (en) * | 2010-02-18 | 2013-05-21 | Biomet Manufacturing Corp. | Method and apparatus for augmenting bone defects |
US8641418B2 (en) | 2010-03-29 | 2014-02-04 | Biomet 3I, Llc | Titanium nano-scale etching on an implant surface |
EP2828100B1 (fr) | 2012-03-20 | 2018-05-16 | Biomet 3i, LLC | Traitement de surface pour une surface d'implant |
Family Cites Families (14)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4512038A (en) | 1979-04-27 | 1985-04-23 | University Of Medicine And Dentistry Of New Jersey | Bio-absorbable composite tissue scaffold |
US5007930A (en) * | 1985-02-19 | 1991-04-16 | The Dow Chemical Company | Composites of unsintered calcium phosphates and synthetic biodegradable polymers useful as hard tissue prosthetics |
US5006120A (en) | 1989-10-10 | 1991-04-09 | Carter Peter R | Distal radial fracture set and method for repairing distal radial fractures |
US5211664A (en) * | 1992-01-14 | 1993-05-18 | Forschungsinstitut, Davos Laboratorium Fur Experimentelle Chirugie | Shell structure for bone replacement |
FR2689400B1 (fr) * | 1992-04-03 | 1995-06-23 | Inoteb | Materiau pour prothese osseuse contenant des particules de carbonate de calcium dispersees dans une matrice polymere bioresorbable. |
US5197966A (en) | 1992-05-22 | 1993-03-30 | Sommerkamp T Greg | Radiodorsal buttress blade plate implant for repairing distal radius fractures |
US5290281A (en) | 1992-06-15 | 1994-03-01 | Medicon Eg | Surgical system |
US5779706A (en) | 1992-06-15 | 1998-07-14 | Medicon Eg | Surgical system |
US5586985A (en) | 1994-10-26 | 1996-12-24 | Regents Of The University Of Minnesota | Method and apparatus for fixation of distal radius fractures |
AU3795395A (en) * | 1994-11-30 | 1996-06-06 | Ethicon Inc. | Hard tissue bone cements and substitutes |
SE505453C2 (sv) | 1995-02-14 | 1997-09-01 | Robert J Medoff | Implanteringsbar stödplatta |
US5868749A (en) | 1996-04-05 | 1999-02-09 | Reed; Thomas M. | Fixation devices |
US7541049B1 (en) * | 1997-09-02 | 2009-06-02 | Linvatec Biomaterials Oy | Bioactive and biodegradable composites of polymers and ceramics or glasses and method to manufacture such composites |
JP2002532160A (ja) * | 1998-12-17 | 2002-10-02 | ケンブリッジ サイエンティフィック, インコーポレイテッド | 皮質骨同種移植片の順序付けられた組み込み |
-
2000
- 2000-12-15 US US09/738,615 patent/US6518328B2/en not_active Expired - Lifetime
-
2001
- 2001-12-14 AU AU2002249805A patent/AU2002249805A1/en not_active Abandoned
- 2001-12-14 WO PCT/US2001/048428 patent/WO2002060337A2/fr not_active Application Discontinuation
- 2001-12-14 EP EP01998045A patent/EP1341473A4/fr not_active Withdrawn
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2007127868A3 (fr) * | 2006-04-27 | 2008-01-10 | Phillips Plastics Corp | Stent composé |
US9101505B2 (en) | 2006-04-27 | 2015-08-11 | Brs Holdings, Llc | Composite stent |
US9155646B2 (en) | 2006-04-27 | 2015-10-13 | Brs Holdings, Llc | Composite stent with bioremovable ceramic flakes |
Also Published As
Publication number | Publication date |
---|---|
US6518328B2 (en) | 2003-02-11 |
WO2002060337A3 (fr) | 2003-02-27 |
EP1341473A4 (fr) | 2006-05-31 |
AU2002249805A1 (en) | 2002-08-12 |
EP1341473A2 (fr) | 2003-09-10 |
US20020127391A1 (en) | 2002-09-12 |
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